Wednesday, March 6, 2013

"...Soon after Joseph Francis learned that his levels of ‘bad’ LDL cholesterol sat at twice the norm, he discovered the short­comings of cholesterol-lowering drugs — and of the clinical advice guiding their use. Francis, the director of clinical analysis and reporting at the Veterans Health Administration (VA) in Washington DC, started taking Lipitor (atorvastatin), a cholesterol-lowering statin and the best-selling drug in pharmaceutical history. His LDL plummeted, but still hovered just above a target mandated by clinical guidelines. Adding other medications had no effect, and upping the dose of Lipitor made his muscles hurt — a rare side effect of statins [not rare at all, just rarely reported by doctors -Tucker], which can cause muscle breakdown.

"So Francis pulled back to moderate Lipitor doses and decided that he could live with his high cholesterol. Later, he learned that other patients were being aggressively treated by doctors chasing stringent LDL targets. But Francis found the science behind the target guidelines to be surprisingly ambiguous. “You couldn’t necessarily say lowering LDL further was going to benefit the patient,” he says.

"The standard advice may soon change. For the first time in more than a decade, the US National Heart, Lung and Blood Institute is revising the clinical guidelines that shaped Francis’s treatment (see ‘How low can you go?’). Expected to be released later this year, the fourth set of guidelines, called [Adult Treatment Panel] IV, has been drawn up by an expert panel of 15 cardiologists appointed by the institute. The guidelines will set the tone for clinical practice in the United States and beyond, and will profoundly influence pharmaceutical markets. They will also reflect the growing debate over cholesterol targets, which have never been directly tested in clinical trials....

"“We can’t just assume that modifying the risk factor is modifying risk,” says Harlan Krumholz, a cardiologist at Yale University in New Haven, Connecticut. “We’ve been burned so many times in the past decade by that assumption.”...

"...In 2011, US doctors wrote nearly 250 million prescriptions for cholesterol-lowering drugs, creating a US$18.5-billion market, according to IMS Health, a health-care technology and information company based in Danbury, Connecticut. “The drug industry in particular is very much in favour of target-based measures,” says Joseph Drozda, a cardiologist and director of outcomes research at Mercy Health in Chesterfield, Missouri. “It drives the use of products.” [Which is good for pharmaceutical companies, less so for patients -Tucker]

"ATP III reflected a growing consensus among physicians that sharply lowering cholesterol would lessen the likelihood of heart attacks and strokes, says Richard Cooper, an epidemiologist at the Loyola University of Chicago Stritch School of Medicine in Illinois, who served on the committee that compiled the guidelines. The committee drew heavily on clinical data, but also took extrapolations from basic research and post hoc analyses of clinical trials. LDL targets were set to be “less than” specific values to send a message, Cooper says. “We didn’t want to explicitly say ‘the lower the better’ because there wasn’t evidence for that,” he says. “But everybody had the strong feeling that was the correct answer.”

"By contrast, the ATP IV committee has pledged to hew strictly to the science and to focus on data from randomized clinical trials, says committee chairman Neil Stone, a cardiologist at Northwestern University School of Medicine in Chicago. If so, Krumholz argues, LDL targets will be cast aside because they have never been explicitly tested. Clinical trials have shown repeatedly that statins reduce the risk of heart attack and stroke, but lowering LDL with other medications does not work as well. The benefits of statins may reflect their other effects on the body, including fighting inflammation, another risk factor for heart disease....

"...“Short people have a higher risk of heart disease,” he says. “But wearing high heels does not lower your risk.”...

From Dr. Eades:

ALERT!Are we experiencing an outbreak of good sense in mainstream medicine?mead.es/XWjFxp